BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY CATHETER

    MDR report key: 2050304 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04113
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT VENTRICULAR LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE GUIDE CATHETER REVEALED AN ABNORMAL CURVE. FLUOROSCOPY REVEALED THAT THE LEFT VENTRICULAR LEAD HAD PERFORATED THE CORONARY SINUS VEIN. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. THE LEFT VENTRICULAR LEAD WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABILIZED AND A LEFT VENTRICULAR LEAD WAS TO BE IMPLANTED IN THE FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CATHETER GUIDE CATHETER DYB EXTERNAL MANUFACTURER 7075

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening